Testing the Addition of a New Anti-Cancer Drug, Glofitamab to Usual Chemotherapy for Burkitt and Double Hit Lymphoma

Summary

This phase II/III trial tests adding glofitamab to standard of care chemoimmunotherapy in patients with Burkitt and high grade (double hit) B- cell lymphomas that are newly diagnosed, that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Glofitamab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Obinutuzumab and rituximab are also monoclonal antibodies. They bind to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make DNA and may kill cancer cells. Chemotherapy drugs, such as cytarabine and ifosfamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Giving glofitamab with standard of care chemotherapy may work well for the treatment of newly diagnosed, relapsed or refractory Burkitt and high grade (double hit) B- cell lymphomas.

Conditions

• Recurrent Burkitt Lymphoma
• Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements
• Refractory Burkitt Lymphoma
• Refractory High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and/or cerebrospinal fluid collection

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Carboplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV or IT

DRUG

Doxorubicin

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Glofitamab

Given IV

DRUG

Ifosfamide

Given IV

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Methotrexate

Given IV or IT

BIOLOGICAL

Obinutuzumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET scan

DRUG

Prednisone

Given PO

BIOLOGICAL

Rituximab

Given IV

BIOLOGICAL

Rituximab and Hyaluronidase Human

Given SC

OTHER

Survey Administration

Ancillary studies

DRUG

Vincristine

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Kristie A Blum · Alliance for Clinical Trials in Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-14

Primary Completion

2033-11-01

Completion

2033-11-01

FDA Drug

Yes